Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of zenoctil in reducing body weight

Conditions: Overweight

Summary: the intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in caucasian subjects. this study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.


Eligibility criteria:
inclusion criteria: * caucasian males and females, age 18 to 60 years * 25 kg/m2 ≤ bmi ≤32 kg/m2 * expressed desire for weight loss * accustomed to 3 main meals a day * consistent and stable body weight 3 months prior to study enrollment * commitment to avoid the use of other weight loss products/programs during the study * commitment to adhere to diet recommendation * females' agreement to use appropriate birth control methods during the active study period * subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply exclusion criteria: * known sensitivity to garcinia cambogia, lagerstroemia speciosa (other members of lythraceae family), caffeine, tannins * history of diabetes mellitus or other endocrine disorders * fasting blood glucose \>7 mmol/l * treatment with systemic corticosteroids within the last 12 months * current use of antidepressants * uncontrolled hypertension (\>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator * presence of acute or history of chronic gastrointestinal disease * schizophrenia or other diagnosed psychiatric disorders * any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, hiv) * bariatric surgery * abdominal surgery within the last 6 months * history of eating disorders like bulimia, anorexia nervosa * changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months * pregnancy or nursing * any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks * more than 3 hours strenuous sport activity per week * history of abuse of drugs, alcohol or medication * smoking cessation within the 6 months prior to this study * incompliance due to language difficulties * participation in another study during the last 4 weeks * clinically relevant excursions of safety parameters

Keywords: overweight weight loss body fat waist circumference satiety appetite
screening cardiovascular patients for aortic aneurysms

Conditions: Abdominal Aortic Aneurysm

Summary: screening studies for abdominal aortic aneurysms (aaa) in 65 to 79 years aged men, have shown a significant reduction in aaa related mortality. in addition, the cost-effectiveness of screening for aaa in men in the netherlands has been demonstrated by using a markov model. screening might be even more (cost-) effective if targeted on high risk groups, such as patients with a particular cardiovascular disease with a known increased risk of having an aaa. project scan (screening cardiovascular patients for aortic aneurysms) is a project focused on targeted aaa screening to proactively diagnose patients at high risk of having an aneurysm that eventually may rupture. this pilot project aims to study the value of a screening protocol in daily practice to detect aaa's in high risk patients.

1. offering pad and cad patients a non-invasive abdominal ultrasound after a careful process of shared-decision making 2. recording data on aneurysm detection on all pad and cad patients screened: 1. general information (age, gender) 2. medical history on cardiovascular risk factors (such as smoking history, hypertension, and other cardiovascular medical conditions - only information that is already recorded in the patient's medical history chart) 3. aaa - yes/ no (yes if ≥3 cm aaa) 4. if ≥3 cm aneurysm, record exact size and outcome in time (surveillance, treatment, no treatment) 5. if treated, record treatment type (evar or open) and outcome

Eligibility criteria:
inclusion criteria: * male and female patients * peripheral arterial disease (ankle brachial index \ 0.15 after exercise test) or a carotid stenosis (stenosis ≥ 50%) * age \> 55 year exclusion criteria: * patients unfit for endovascular or open surgery (as judged by vascular surgeon) * failure to master the dutch language
magnesium and cognition after stroke

Conditions: Stroke; Cognition; Magnesium; Neurologic Disorder

Summary: cognitive impairments such as memory impairments, word-finding difficulties, compromised orientation and perception are often observed in stroke patients. low serum-mg-concentrations are associated with cognitive impairments in ischemic stroke patients one month after stroke onset. it is not clear, if cognitive impairments after stroke is caused by the mg-deficiency or by the stroke itself. until now, no studies investigating the relationship between mg-concentration, stroke severity and cognition during treatment course are available. thus, this study aimed to investigate the relationship between mg-concentration and cognition of stroke patients.

stroke patients admitted to the stroke unit will be included. initial mg-concentration in serum as well as stroke related measures (national institutes of health stroke scale, scandinavian stroke scale, modified rankin scale) will be ealuated. moreover, the cognitive abilities of the patient will be assessed within the first three days via the kölner neuropsychologische screening for stroke patients as well as the mini mental status test. during stroke rehabilitation mg-level, stroke related measures (nihss,sss,mrs) as well as the cognitive tests (mmst,köpss) will be re-assed after 4 weeks, 3 month as well as at study end, which is defined as discharge from the clinic (death, transfer to another hospital without return after 4 weeks, discharge to long-term nursing/ home/hospice). attention-network of stroke patients are measeared if the patient undergo a mri scan. in this study following questions will be assessed: 1. what is the incidence of cognitive impairments in stroke patients? 1. are there differences between ischemic and hemorrhagic stroke patients? 2. are there age and/or gender differences? 2. are there differences regarding the mg-concentration at admission in comparison to the follow-up (week 4 after admission, 3 month after admission) and between patients with/without cognitive impairments? 3. is there a correlation between the mg-concentration and the stroke severity? 4. is there a correlation between the scores of the different cognitive tests (mmst and köpss)? 5. is there an association between the stroke severity, the cognitive impairments (köpss) and the neuronal attention network?

Eligibility criteria:
inclusion criteria: * ischemic/hemmorhagic stroke * written consent form exclusion criteria: * pre-existing dementia or cognitive impairment before stroke onset * pre-existing mental disorder (depression) or present/prior long-term treatment (\> 6 months) with psychotropic drugs * pre-existing malign tumor disease * participation in another clinical trial within the past 30 days * pregnancy or breastfeeding
characterizing protein biomarkers of post-infection irritable bowel syndrome

Conditions: Post-infectious Irritable Bowel Syndrome; Irritable Bowel Syndrome

Summary: the investigators will characterize and compare protein signatures between groups with and without post-infection irritable bowel syndrome (pi-ibs). from previous healthy nevada project (hnp) participants, at least 60 patients with pi-ibs and 60 healthy controls will undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. the investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. serum samples will be analyzed by the nevada proteomics center. samples will first undergo protein digestion, then peptides are separated using liquid chromatography (lc), mass spectral analysis is performed using an orbitrap eclipse mass spectrometer (thermo scientific, san jose, ca) using data-independent acquisition (dia). library generation and data analysis will be performed using spectronaut software (biognosys, schlieren, switzerland). the nevada proteomics center and bioinformatics center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. this research aim has the potential to add to our understanding of the underlying mechanisms of pi-ibs and to create reliable differentiating protein biomarkers to better diagnose pi-ibs.

the investigators will characterize and compare protein signatures between groups with and without pi-ibs. from previous hnp participants, at least 60 patients with pi-ibs and 60 healthy controls will be recruited to undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. the investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. serum samples will be analyzed by the nevada proteomics center. samples will first undergo protein digestion, then peptides are separated using liquid chromatography (lc), mass spectral analysis is performed using an orbitrap eclipse mass spectrometer (thermo scientific, san jose, ca) using data-independent acquisition (dia). library generation and data analysis will be performed using spectronaut software (biognosys, schlieren, switzerland). the nevada proteomics center and bioinformatics center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. this research aim has the potential to add to our understanding of the underlying mechanisms of pi-ibs and to create reliable differentiating protein biomarkers to better diagnose pi-ibs.

Eligibility criteria:
inclusion criteria: * participants must have a healthy nevada project record and linked renown health medical record * must be between 18 and 89 years of age * must have previously consented to being contacted and have updated contact information exclusion criteria: -none
effect of pravastatin on endothelial dysfunction following a single high fat meal

Conditions: Heart Diseases

Summary: there is significant evidence that hmg-coa reductase inhibitors, a commonly used class of cholesterol lowering medications, reduce the risk of death from coronary disease. although these medicines lower cholesterol levels, other studies suggest that they have an additional effect on improving blood vessel functioning. it has also been shown that consumption of a fatty meal temporarily alters blood vessel functioning, causing endothelial dysfunction. this study will examine if pravastatin, an hmg-coa reductase inhibitor, improves blood vessel functioning after a fatty meal. we plan on enrolling 32 subjects, aged 18-40 years, who are healthy with no history of diabetes, smoking, high blood pressure, or heart disease. these subjects will be randomly assigned to initially receive four days of pravastatin or an inactive substance, and then crossed over to the other group. blood vessel functioning will be monitored by a technique called flow mediated vasoactivity, which uses ultrasound measurement of the forearm artery and its response to temporary occlusion. this primary measure of flow mediated vasoactivity will be done before and after consumption of a fatty meal. we hope to show that treatment with pravastatin prevents the blood vessel dysfunction known to occur after a high fat meal. secondary outcomes will include measurement of endothelin-l, a mediator of blood vessel functioning, and assessment of changes in lipid profiles. if pravastatin does prevent endothelial dysfunction in this setting, it could lead to further studies about their use in more acute medical settings, including heart attacks or strokes.


Eligibility criteria:
inclusion criteria: * no history of the following: hypertension, diabetes mellitus, smoking, and coronary artery disease

Keywords: endothelial dysfunction
water immersion and polyp detection: a randomized controlled trial

Conditions: Adenoma; Colonic Neoplasms

Summary: we plan to conduct a randomized trial of tandem colonoscopies comparing water infusion and air insufflation for inspection of mucosa on withdrawal. in one randomized group, water infusion will be employed as the first method for mucosal inspection while in a second group, co2 insufflation will be used first. this study will be different than usual care since the participants will receive two successive or tandem colonoscopies versus one


Eligibility criteria:
inclusion criteria: * all adults 50 years or older who present for colonoscopy at white river junction vamc and indiana university exclusion criteria: * includes co-morbid status of asa iii or higher, inflammatory bowel disease (ibd), surgical resection of the large bowel, as well as the use of anticoagulants. finally, potential subjects who do not report a clear effluent in the most recent bowel movement will be excluded from the study.
resistant arterial hypertension cohort study

Conditions: Hypertension; Essential Hypertension; Resistant Hypertension

Summary: the purpose of this study is to investigate the epidemiology of resistant hypertension, evaluate the efficacy and feasibility of a standardized drug treatment regimen (including the randomization of two doses of the diuretic used - chlorthalidone), study two interventions in the group of patients that is non-compliant, and study environmental and genetic variables of individuals with resistant hypertension in a family design.


Eligibility criteria:
inclusion criteria: * informed consent * resistant hypertension at the moment of inclusion * 18 years or more, both sexes are included * women at reproductive age: consenting to use oral contraception exclusion criteria: * patients mentally impaired or unable to give informed consent * patients speaking only a foreign language other than french, german, or english * patients living far away, making the study visits not practical
fatigue and hearing loss.

Conditions: Hearing Loss; Fatigue

Summary: an intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables. the study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care.

hearing impairment leads to increased listening effort which could result in short and/or long term fatigue. previous research has shown that people with a hearing loss score higher on fatigue questionnaires than people without a hearing loss. hearing aid fitting has been shown to reduce fatigue in an objective measurement study, however no reduction has been shown using subjective measurement. to examine the effect of hearing aid fitting on fatigue a longitudinal study will be conducted. a battery of questionnaires measuring fatigue, listening effort, daily activity, need for cognition and hearing handicap as well as an objective hearing test will be conducted at 4 time points. these time points will be a baseline assessment before hearing aid fitting, 2 weeks after fitting (\~3 months after baseline), 3 months after fitting and 6 months after fitting. a control group with no change in hearing aid status will also be measured at these time points. the study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care. this study monitors the effect of the hearing aid fitting. the general hypothesis is that hearing aid fitting will reduce fatigue. more specifically it is expected that fatigue will increase immediately after fitting and then decrease by the 6 month time point. it is also expected that social activity levels will increase after fitting and that individual differences in this activity change will explain some of the differences between participants in rate of change in fatigue. it is predicted that high need for cognition and hearing handicap scores will increase the amount of change in fatigue for the intervention group. 57 participants will be recruited for each group, each participant being involved in the study for no more than 7 months with the study running for a total of 15 months. the data will be analysed using multi-level analysis.

Eligibility criteria:
inclusion criteria: * a self-reported hearing loss. * aged between 18 and 75 years old. inclusion criteria for intervention group only: * must already have an appointment arranged to receive a hearing aid for the first time. inclusion criteria for control group only: * no change in hearing aid status (including new models) for the past 1 year. exclusion criteria: * non fluent english speakers. (to maintain validity of results as english language questionnaires are used) * inability to read (in order to complete the questionnaires). * inability to visit on multiple occasions over 7 months (e.g. can't be planning to move away from the area). * inability to give full informed consent. * primary complaint of tinnitus.
time restricted feeding for weight loss and cardio-protection

Conditions: Coronary Disease; Weight Loss

Summary: time restricted feeding (trf) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. trf is effective for weight loss and cardio-protection in obese adults. it is of great interest to see whether subjects can adhere to trf for longer periods of time, and to see what degree of weight loss that can be achieved with trf. accordingly, the aims of this trial are: aim 1: to determine if trf can be implemented to facilitate weight loss in obese adults, and aim 2: to determine if trf can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.

time restricted feeding (trf) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. recent findings from short-term uncontrolled trials suggest that trf is effective for weight loss and cardio-protection in obese adults. in view of these pilot findings, it is of great interest to see whether subjects can adhere to trf for longer periods of time, and to see what degree of weight loss that can be achieved with trf. accordingly, the aims of this trial are: aim 1: to determine if trf can be implemented to facilitate weight loss in obese adults, and aim 2: to determine if trf can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers. to test the study objectives, a 14-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline; and (2) 12-week weight loss, will be implemented. obese subjects (n = 40) will be randomized to 1 of 2 groups: (1) trf (n = 20), or (2) control (n = 20). this study will be the first randomized controlled trial of trf, and will show that trf can be implemented to help obese individuals lose weight and lower risk of coronary heart disease.

Eligibility criteria:
inclusion criteria: * male or female * body mass index (bmi) between 30.0 and 40 kg/m2 * age between 25 and 65 years * sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week) * weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg) * able to give written informed consent exclusion criteria: * smoker * diabetic * history of cardiovascular disease (myocardial infarction or stroke) * taking weight loss medications * history of eating disorders * night-shift workers * perimenopausal * pregnant or trying to become pregnant
triamcinolone paste to reduce the incidence of postoperative sore throat

Conditions: Tracheal Intubation

Summary: the purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.

sore throat is a common postoperative complaint after tracheal intubation. when the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii, aged between 20 and 70 years * scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation exclusion criteria: * recent respiratory tract infection or sore throat * who were using analgesics or steroid preoperatively * who have risk factors for oral cavity infection * the surgical duration \ 300 minutes

Keywords: postoperative sore throat tracheal intubation lubrication triamcinolone
study of ro 205-2349 in patients with type 2 diabetes mellitus

Conditions: Diabetes

Summary: the objective of the study is to determine the dose(s) of ro 205-2349 which, when compared to placebo, are efficacious, safe and tolerable in improving glycemic control in patients with type 2 diabetes. doses of 5 to 20 mg/day will be studied.


Eligibility criteria:
inclusion criteria: * age 35 to 75 * type 2 diabetes for longer than 3 months * hba1c (glycosylated hemoglobin a1c) greater than 7.0% at screening * fpg (fasting plasma glucose) greater than 126 mg/dl at screening * bmi (body mass index) less than 40 kg/square meter exclusion criteria: * type i diabetes * type 2 diabetes patients currently treated with insulin * type 2 diabetes patients currently or previously treated with actos, avandia or rezulin * fpg (fasting plasma glucose) greater than 270 mg/dl at baseline * impaired liver or kidney function * triglycerides greater than 600 mg/dl * uncontrolled hypertension * pregnant or lactating women * women not using adequate contraception